Abstract
Purpose
Everolimus with exemestane (EVE+EXE) was FDA-approved to treat metastatic hormone
receptor-positive breast cancer (mHRBC) based on BOLERO-2. However, none of those
patients received prior CDK4/6 inhibitors. The purpose of this study is to evaluate
the efficacy of EVE+EXE in mHRBC after CDK4/6 inhibitors.
Methods
A retrospective review of patients ≥18 years old with mHRBC treated with EVE+EXE,
for ≥30 days, at our institution from January 1, 2012, to April 1, 2020 was conducted.
Primary objective was to compare progression free survival (PFS) for EVE+EXE between
patients with and without prior exposure to CDK4/6 inhibitors. Secondary outcomes
included overall survival and safety.
Results
192 patients were included in the study (n = 79, prior CDK4/6 inhibitor use; n = 113,
no prior CDK4/6 inhibitor use). Baseline patient characteristics were similar between
groups. Greater number of prior therapies before EVE+EXE use increased risk of disease
progression (P = .017). Patients with prior CDK4/6 inhibitor use had a lower median PFS of 3.8 months
(95% CI: 3.4-4.7) vs. 5.4 months (95% CI: 3.9-6.2) for patients without prior CDK4/6
inhibitor use, with a HR for progression of 1.46 (95% CI: 1.08 to 1.97, P = .013). Overall survival between groups was not significantly different.
Conclusion
Patients who received a prior CDK4/6 inhibitor had a lower median PFS benefit from
EVE+EXE compared to those who did not, without differences in overall survival. Although
PFS is expected to decrease with subsequent lines of therapy, it is reasonable to
use EVE+EXE after CDK4/6 inhibitors in selected patients, recognizing that additional
benefit is modest.
Keywords
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Article info
Publication history
Published online: October 08, 2021
Accepted:
October 3,
2021
Received in revised form:
September 5,
2021
Received:
May 4,
2021
Identification
Copyright
© 2021 Elsevier Inc. All rights reserved.
